Label: TUSSIN DM- guaifenesin and dextromethorphan hydrobromide liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 54868-1934-1, 54868-1934-2 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 54838-209
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 17, 2011
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TUSSIN DM
guaifenesin and dextromethorphan hydrobromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1934(NDC:54838-209) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength citric acid (UNII: 2968PHW8QP) FD&C red no. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) menthol (UNII: L7T10EIP3A) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) saccharin sodium (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sucrose (UNII: C151H8M554) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor STRAWBERRY (STRAWBERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-1934-1 118 mL in 1 BOTTLE, PLASTIC 2 NDC:54868-1934-2 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/03/2009 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel, repack